A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients

• Status: Completed
• Trial end date: 2020-01-16
• Target enrollment: 0
• Participant gender: All

Summary

This study will investigate the effect of co-administration of Triferic and heparin on the ability to maintain circuit anti-coagulation and iron delivery when compared to control conditions when each treatment is administered via separate routes.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rockwell Medical Technologies, Inc.
• Treatments: Calcium heparin; Citric Acid; Heparin; Iron

Criteria

Inclusion Criteria:

1. Adult hemodialysis patients ≥18 years of age.

2. Signed informed consent to participate in the study.

3. Stable on hemodialysis prescription for ≥3 months.

4. Hemoglobin concentration >9.5 g/dL.

5. Serum TSAT ≥20%.

6. Able to receive continuous heparin infusion as their anticoagulation protocol.

7. Receiving hemodialysis via AV (arteriovenous) fistula or graft.

8. Able to receive hemodialysis for 4 hours at each session over the duration of the treatment periods.

Exclusion Criteria:

1. Active bleeding disorder (GI, skin, nasal…)

2. Receiving hemodialysis via catheter.

3. Receiving heparin free dialysis.

4. Receiving low molecular weight heparin as sole anti-coagulation for dialysis.

5. Receiving IV iron within 2 weeks of the first on-study hemodialysis treatment.

6. Receiving oral anti-coagulants or anti-platelet agents.

7. Any other condition, that in the opinion of the investigator would not allow completion of the 3 hemodialysis treatments in the study.